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PLEASE: Do not abruptly stop taking an antidepressant or other psychoactive medication.

* Many of you may feel you are the only one going through whatever you are going through. We assure you, you are not. The link that follows will open a new browser window. Just click the X at the top right of your screen when finished and you will return to this page. Take the time and read this, you can make it back. Click here.

Newsletters - Beginning May 7, 2008 we will be providing our newsletters on this Web Site. There are several newsletters since 1999 that will be posted and will be adding them as quickly as possible. Until then, as new newsletters are published, they will added to the site upon publication. Click here to read newsletters.

August 17, 2007 - The Road Back is pleased to announce the addition of another healthcare facility implementing The Road Back Program.

We welcome The Institute for Detoxification and Health, located in The Woodlands, Texas, a suburb of Houston.

The Institute for Detoxification and Health brings a rather refreshing and unique approach to assist individuals regain their health and well-being.

If you are wanting to taper off a drug, are already off a drug but still suffering or contemplating using a drug, The Institute for Detoxification and Health is fully set up to assist. 

The detoxification process: 

Stage 1 detoxification is: tapering off a medication with medical supervision. 

Stage 2 detoxification is: the removal of residual toxins that remain stored in the body tissue after a Stage 1 detoxification is complete.

The Institute for Detoxification and Health offers Stage 1 and Stage 2 detoxification.

The Institute for Detoxification and Health will assist each individual with the implementation of The Road Back Program during Stage 1 and Stage 2 of the detoxification process. 

Coming off these medications incorrectly can cause trauma or mental anguish. The mental anguish can keep a person on the drug or make them feel like they may need another drug just to squelch the daily withdrawal side effects that have persisted for months or years after the last dosage was taken. The Institute for Detoxification and Health can assist those individuals.

How do we overcome the ups and downs in life? How do we overcome the ups and downs of withdrawal? The Institute for Detoxification and Health will offer assistance.

Once a person is off psychiatric medication for 45-days, The Road Back Program urges everyone to have a competent doctor evaluate their hormones, thyroid, adrenals, cortisol, insulin resistance and the entire loop found within the pituitary system. This is the area nearly all side effects from psychiatric medication can be traced. The Institute for Detoxification and Health has the trained staff.

The Institute for Detoxification and Health now fills a major gap to complete the goal of The Road Back. That goal is: a person off psychoactive medication safely, a person able to remove the stored drug residuals from their tissue, a person able to have assistance handling any and all mental trauma created by the drug, and a person able to address and handle why they went on the drug in the first place

The Institute for Detoxification and Health is an outpatient facility. If you live in or near the Houston, Texas metro area, you now have a local solution.

The Institute for Detoxification and Health will open their new Stage 2 detoxification facility August 14, 2007.

If you have already tapered off your medication, you are ready to begin the Stage 2 detoxification process. Do not wait.

If you are using The Road Back Program and you live in the Houston area, contact The Institute for Detoxification and Health.

I certainly hope I come across as being very excited about The Institute for Detoxification and Health.

For the first time, a healthcare facility offers:

  • A non-drug approach to assist individuals to taper off psychiatric medication
  • Medical Doctors to first rule out any underlying disease or illness before starting the taper program
  • Medical Doctor supervision with the tapering portion of the program
  • Healthcare providers assisting with the pre-taper and nutritional implementation
  • Chiropractic assistance
  • Acupuncture
  • Alternative Medicine
  • Stage 2 detoxification process to complete the physical portion of The Road Back Program
  • Assistance with mental trauma

The Institute for Detoxification and Health can be reached by calling 1 – 281 – 362 – 7005. If you are in or near the Houston, Texas area, I urge you to take full advantage of their valued service.

Best,

Jim Harper
The Road Back

May 2, 2007 - FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

"The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

"Today's actions represent FDA's commitment to a high level of post-marketing evaluation of drug products," said Steven Galson, M.D., MPH, director of FDA's Center for Drug Evaluation and Research. "Depression and other psychiatric disorders can have significant consequences if not appropriately treated. Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks."

People currently prescribed antidepressant medications should not stop taking them. Those who have concerns should notify their health care providers.

The proposed labeling changes apply to the entire category of antidepressants. Results of individual placebo-controlled scientific studies are reasonably consistent in showing a slight increase in suicidality for patients taking antidepressants in early treatment for most of the medications. Available data are not sufficient to exclude any single medication from the increased risk of suicidality.

The proposed labeling update follows similar labeling changes made in 2005 that warned of a suicidality risk in children and adolescents who use antidepressants. At that time, FDA asked manufacturers to add a black box warning to the labeling of all antidepressants to describe this risk and to emphasize the need for appropriate monitoring and close observation, particularly for younger patients taking these medications. In addition, FDA directed manufacturers to develop Medication Guides, FDA-approved user-friendly information for patients, families and caregivers, that could help improve monitoring. Medication Guides are intended to be distributed at the pharmacy with each prescription or refill of a medication.

Also in 2005, FDA began a comprehensive review of 295 individual antidepressant trials that included over 77,000 adult patients with major depressive disorder (MDD) and other psychiatric disorders, to examine the risk of suicidality in adults who are prescribed antidepressants.

In December 2006, FDA's Psychopharmacologic Drugs Advisory Committee agreed that labeling changes were needed to inform health care professionals about the increased risk of suicidality in younger adults using antidepressants. Additionally, the committee noted product labeling needed to reflect the apparent beneficial effect of antidepressants in older adults and to remind health care professionals that the disorders themselves are the most important cause of suicidality.

FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.

Products involved in today's action include:

Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl
Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Pexeva (paroxetine mesylate)
Prozac (fluoxetine HCl)
Remeron (mirtazapine)
Sarafem (fluoxetine HCl)
Seroquel (quetiapine)
Sinequan (doxepin)
Surmontil (trimipramine)
Symbyax (olanzapine/fluoxetine)
Tofranil (imipramine)
Tofranil-PM (imipramine pamoate)
Triavil (perphenazine/amitriptyline)
Vivactil (protriptyline)
Wellbutrin (bupropion HCl)
Zoloft (sertraline HCl)
Zyban (bupropion HCl)"


Our prayers and condolences go out to the students, family, and residents of Virginia. 

News is coming out the shooter at Virginia Tech was using an antidepressant.

The shooter had recently been referred to the school’s counseling service. If the shooter actually went to the school’s counseling service, he probably would have been prescribed the antidepressant at that time.

  • There is usually a sudden urge for people to stop taking their antidepressant when a horrific news story comes out and antidepressants are involved.
     

  • PLEASE: Do not abruptly stop taking an antidepressant.

By Aamer Madhani
Tribune national correspondent
Published April 17, 2007, 1:52 PM CDT
Cho had shown recent signs of violent, aberrant behavior, according to an investigative source, including setting a fire in a dorm room and allegedly stalking some women.

A note believed to have been written by Cho was found in his dorm room that railed against "rich kids," "debauchery" and "deceitful charlatans" on campus.

Cho was an English major whose creative writing was so disturbing that he was referred to the school's counseling service, the Associated Press reported
.”

The recent aberrant behavior usually happens when an antidepressant is initially started or when an antidepressant dosage is increased.

Antidepressants have different effects on all individuals. Their own clinical trials demonstrate these phenomena.

A person with depression may feel dull but no longer depressed after starting an antidepressant. However, another person with depression may be more depressed after starting an antidepressant. The same holds true when an antidepressant dosage is increased.

An individual with violent, anger tendencies, agitation, etc, may become more so when an antidepressant is started or a dosage is increased.

The same holds true when an antidepressant is reduced abruptly.

There is no way to tell which turn in the road a person will make regarding side effects.

What is known:
Antidepressants metabolize through the body using a specific route. That route is called CYP. There are several CYP routes but all antidepressants utilize a route called CYP2D6. Within the CYP2D6 you will find several other variations that can take place that allow or do not allow a drug to pass through with ease.

The first large-scale study to examine the genetic polymorphism of CYP2D6 in an Asian population was conducted by the Department of Laboratory Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

What was found in this study: If an Asian were to take any drug that uses the CYP2D6 to metabolize, up to 46% of the Asian population will not be able to metabolize the drug normally. There will be a build up of the drug in the body and the drug may take as long as 42 hours to clear, instead of the normal 18 hours.

One variation within the CYP2D6 is called CYP2D6*10 allele. Forty-five percent of of the Asian population will have this DNA variation. This 45% Asian population base can count on adverse drug reactions, sooner rather than later.

For other Asians, the drug will shoot through the liver enzymes too quickly and not have a chance to break down as designed, and a build up of the metabolites from the drug will occur.

PLEASE: Do not abruptly stop taking an antidepressant.

If you want to discontinue your antidepressant, please get with the prescribing physician and discuss how you are going to get off the antidepressant.

  • Taper off the antidepressant slowly
  • Do not skip days taking the medication
  • Take your physician a printout of the tapering information found on this site

Our recommend reduction method can be found by clicking here

How Has Drug Use Changed in 2007?

  • Teens and young adults now abuse psychiatric prescription drugs more frequently than illegal street drugs, such as cocaine and marijuana.

With that being the case and with the side effects that happen when psychiatric drugs are abruptly stopped or days are skipped between taking the psychiatric drug, what can we expect in the future?

If you are a parent with children, please keep your medication safe.

If you are a parent and you find out your child has been abusing psychiatric drugs, please do not abruptly stop your child from taking the drug. Inform your physician and have the child slowly taper off the drug.

April 19, 2007 -

The Journal of Clinical Psychiatry has issued the following findings: “Patients taking antipsychotic drugs for schizophrenia often produce little or no hormone in the sex glands.”

If you are a parent of a child prescribed an antipsychotic drug, you may be coming to the wrong conclusion by this opening statement. You may think, “My child does not have schizophrenia, so this does not apply to my child.”

The antipsychotic drug causes the condition known as hypogonadism and not the schizophrenia.

What is hypogonadism?

Hypogonadism is a medical term for a defect of the reproductive system which results in lack of function of the gonads (ovaries or testes).

The gonads have two functions: to produce hormones (testosterone, estradiol, antimullerian hormone, progesterone, inhibin B), and to produce eggs or sperm.

Deficiency of sex hormones can result in defective primary or secondary sexual development, or withdrawal effects (e.g., premature menopause) in adults. Defective egg or sperm development results in infertility.

The term hypogonadism is usually applied to permanent rather than transient or reversible defects, and usually implies deficiency of reproductive hormones, with or without fertility defects. The term is less commonly used for infertility without hormone deficiency.

The facts from this study:

If you are a female taking an antipsychotic drug, you have a 15-fold likelihood of sexual dysfunction.

If you are a male taking an antipsychotic drug, you have a 9-fold likelihood of sexual dysfunction.

If you are female, pre-menopausal, low estrogen production, taking an antipsychotic drug; you have a 79% chance of developing sexual dysfunction.

If you are a female with low progesterone levels, you have a 92% chance of developing sexual dysfunction.

Dr. Oliver D. Howes, Institute of Psychiatry, London, states, “ The high rates of hypogonadism suggest that patients are at increased risk of cardiovascular disease and osteoporosis.” Additionally, “Clinicians are advised to inquire about sexual dysfunction and monitor...hormone levels in patients taking antipsychotics.”

Of note, this clinical trial was with patients taking antipsychotics for only six months or longer and did not evaluate the hypogonadism-increased risk with children.

1 out of every 5 children that visit a psychiatrist are prescribed an antipsychotic drug.

PLEASE: Do not abruptly stop taking an antipsychotic.

October 25, 2006 - Source FDA -

Effexor XR (venlafaxine HCl) Extended-Release Capsules
Effexor (venlafaxine HCl) Tablets
Audience: Neuropsychiatric and other healthcare professionals
[Posted 10/25/2006] Wyeth and FDA notified healthcare professionals of revisions to the OVERDOSAGE/Human Experience section of the prescribing information for Effexor (venlafaxine HCl), indicated for treatment of major depressive disorder. In postmarketing experience, there have been reports of overdose with venlafaxine, occurring predominantly in combination with alcohol and/or other drugs. Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcome compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Healthcare professionals are advised to prescribe Effexor and Effexor XR in the smallest quantity of capsules consistent with good patient management to reduce the risk of overdose.

September 21, 2006 CBC - Ritalin, Adderall and all other drugs used to treat attention deficit hyperactivity disorder have the potential to cause uncommon psychiatric side-effects including rare cases of agitation and hallucination in children, Health Canada warned Thursday.

The department announced all drugs used to manage ADHD will carry new labels in December. Prescribing information will also be updated, based on an ongoing review of psychiatric events linked to the drug.

Two million prescriptions for the stimulants, which increase blood pressure and speed up the pulse, were written in Canada in 2005, and use of the drugs is increasing.

The psychiatric warning follows the department's May 2006 alert on rare heart-related risks for all ADHD drugs.

Canadian adults and children were advised not to use the drugs if they have high blood pressure, heart disease or other heart problems, hardening of the arteries or an overactive thyroid gland. Drug labels were standardized to report the risk of rare heart-related side-effects.

"ADHD drugs are generally safe and provide benefits for Canadians in their treatment of ADHD when used as directed," Health Canada said in a release.

People should check with a doctor about taking the drugs or if they have questions or concerns.


July 10, 2006 all major news networks ran a story regarding Effexor and hostility and violent tendencies. Hostility and violent tendencies are now a listed side effect of Effexor.

Of note in the initial story, it was disclosed the the rare side effects from Effexor as well as other psychoactive medication means 1 in 1,000. If you were told hostility or violent tendencies would be a rare side effect would you have guessed 1 in a million or about as much chance of winning the lottery?

One reporter however is being misled by at least one psychiatrist: "In psychiatry we always say, 'What can we do about the infrequent, random event, and how do we warn about the risk?' " Streusand said. "So for medical and legal reasons, you explain to everyone the risk."

Were you explained the risk? Were you told you had a 1 in 1,000 chance of bleeding from the eye socket, having heart palpitations, a sudden and violent drop in blood pressure, anemia, develop joint disease, amnesia, hostility and violent tendencies or any of the side effects listed by clicking here. Were you told you could gain 50 pounds of weight or more and not be able to lose it?

If you would like to help the reporter get the facts straight you can contact her by e-mail at445-3619 to reach by telephone AMERICAN-STATESMAN STAFF.

Let Mary Ann know your story, what you have been through and make sure to let her know if your physician fully explained the risk to you.

 

Questions raised about drug Yates was taking
'Homicidal ideation' one of the rare adverse side effects

 Reported by ANGELA K. BROWN
Associated Press Writer

HOUSTON (AP) -- An antidepressant that Andrea Yates had been taking before she drowned her five children in 2001 has recently been found to possibly increase the risk of homicidal thoughts, according to a medical watchdog group that says Effexor's manufacturer has not warned the public.

"Homicidal ideation" was added last year as one of the drug's rare adverse events on Effexor XR's label and on Wyeth's Web site.

The U.S. Food and Drug Administration defines rare as occurring in less than one in 1,000 people. In the U.S. alone, about 19.2 million prescriptions for Effexor were filled last year, but that does not reflect the number of people who take the drug because some of those are refills.

Dr. Moira Dolan, executive director of the Medical Accountability Network, said she discovered the labeling change about two weeks ago when she stumbled across the FDA's MedWatch newsletter from November. The Madison, N.J.-based drug company did not send letters to doctors or issue warning labels.

"People need to be warned that this is a possible side effect," Dolan, an Austin doctor who has reviewed Yates' medical records but is not involved in the case, said Sunday. "Families don't know to be aware of this possible effect. As doctors, we're not going to look through 36 pages of labeling."

Effexor is Wyeth's top-selling drug, with $3.46 billion in 2005 sales worldwide, more than twice the total for its No. 2 product and 18 percent of its total revenues for last year.

"We believe there is no causal link between Effexor and homicidality," said Wyeth spokeswoman Gwen Fisher. "In our minds, we've taken every precaution."

She said that as Effexor was being studied for use in treating panic disorder, Wyeth found that only one person reported having homicidal thoughts in its clinical trial. Fisher said she did not know the trial date.

In approving Wyeth's application to use Effexor for that disorder, the FDA wanted homicidal ideation listed as a rare adverse event, defined as something not proven to be linked to the drug, Fisher said. That is different from an adverse reaction, she said.

Wyeth never notified doctors or issued warning labels because it found no causal link between its drug and homicidal thoughts, Fisher said.

Dolan said the current Web site label mentions homicidal thoughts in the middle of a paragraph on page 36. Fisher said the warning about "homicidal ideation" also appears on the one-page package insert given to all patients.

In 2004, the FDA ordered that all antidepressants carry "black box" warnings that they increase the risk of suicidal thinking and behavior in children. That action was driven by data that showed that, on average, 2 to 3 percent of children taking antidepressants have increased suicidal thoughts and actions. The link is stronger with Effexor than with other antidepressants in the same class of drugs.

James T. O'Donnell, assistant professor of pharmacology at Rush University Medical Center in Chicago and the author of "Drug Injury: Liability, Analysis, and Prevention," said the homicidal ideation issue should be on the same level of public awareness.

"For something as final as homicide, that's important to know about," O'Donnell said.

But Fisher said the drug is safe and effective. Yates, who remains jailed, continues taking Effexor as well as an anti-psychotic drug to help stabilize her mental illness, according to a psychiatrist testifying in Yates' retrial that started two weeks ago.

Yates, 42, has pleaded innocent by reason of insanity in her second murder trial. Her 2002 capital murder conviction was overturned on appeal because some erroneous testimony may have influenced jurors.

Yates had been prescribed Effexor in varying doses since shortly after her first suicide attempt in 1999, said Dolan, who reviewed her medical records after her first trial at the request of her then-husband, Rusty Yates. A month before the murders, her daily dose had increased to 450 mg, twice the recommended maximum dose, Dolan said.

Her lead attorney, George Parnham, has criticized the amount of medications Yates was prescribed before the children's bathtub drowning deaths. He said Wyeth should have publicized information about the possible connection between Effexor and thoughts of murder, but he said that will not affect Yates' case.

"Obviously this is a severely mentally ill individual who was on a plethora of psychiatric meds," Parnham said. "There's no question mental illness killed those children."

Parnham said Yates suffered from postpartum psychosis and drowned the children in the family bathtub while in a delusional state, which likely was exacerbated after she was suddenly taken off Haldol, a strong anti-psychotic drug.

Yates, being tried in only three of the deaths, will be sentenced to life in prison if convicted.

Effexor sales rose only 3.3 percent in 2005, compared with 2004, but jumped 8.8 percent in the first quarter of this year, to $945 million.

AP Business Writer Linda A. Johnson in Trenton, N.J., contributed to this report.

AP-ES-07-09-06 2142EDT
Published: July 10. 2006 1:19PM

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